A Compilation of Letters

Thank you for your further correspondence of December 7, 2011, concerning the safety of GardasilTM.

The Public Health Agency of Canada (PHAC) is aware that an unpublished report claims to have identified contamination in the form of recombinant human papillomavirus (HPV) DNA in vials of GardasilTM (manufactured by Merck Canada) from different lots.

GardasilTM contains recombinant HPV DNA fragments, but these are considered necessary to the vaccine manufacturing process and are not contaminants. The presence of these DNA fragments in this vaccine is not a risk to recipients and poses no safety concern.

The safety of vaccines is of the utmost importance to the federal government. Canadians can be confident that all health products are authorized for sale by Health Canada only after undergoing rigorous reviews to ensure their safety, efficacy and quality. In addition, all reports of adverse events following immunization are reviewed in a timely manner, and if warranted, further investigated by PHAC and the provincial ministries of health.

NEWS RELEASE
April 30, 2007Is Ottawa making guinea-pigs of Canadian girls?

OTTAWA, April 30, 2007: The federal government has allocated $300 million in its 2007 budget for a proposal to vaccinate our daughters and granddaughters against a disease that can cause cervical cancer. The plan targets adolescent and pre-adolescent girls for a vaccine called Gardasil.

Gardasil is a recently-devloped vaccine for human papilloma virus (HPV), a viral infection that has become a virtual epidemic because of sexual promiscuity.

Merck-Frosst developed Gardasil, and has been promoting it to governments in Europe and North America for the vaccination of young girls—girls as young as nine, in some jurisdictions—in spite of the fact that it has never been tested on children that young, and in some women among whom it has been tested, it has had serious side effects.

The proposal for universal vaccination of young girls—and boys, too, in Austria—is hopefully intended to eradicate the virus, without trying to change the behaviour that spreads it.

Universal vaccination of children for a sexually transmitted disease opens the door for unintended consequences, for it also telegraphs the dangerous message that says, “Society expects you to behave promiscuously; we don’t believe you can learn to behave responsibly, so the government will take care of the consequences of your irresponsible behaviour.”

That’s a bad and dangerous message.

And there may be another reason for promoting mandatory Gardasil vaccinations: Vioxx.

Vioxx was an inadequately-tested pain-killer, marketed by Merck, that apparently caused heart attacks and strokes. Lawsuits from Vioxx cost Merck more than a billion dollars.

Canadians should ask whether Ottawa’s Gardasil campaign is an attempt to bail Merck out after the Vioxx disaster. Certainly, the similarly premature government promotion of Gardasil is the wrong answer.

It is also alarming to learn, from an Ottawa Citizen report, that a former policy advisor to Prime Minister Harper is the point-man for Hill & Knowlton, one of Canada’s biggest lobbyists, to promote Gardasil for Merck.

Our daughters and granddaughters should not be the guinea-pigs in an attempt to bail out Big Pharma. The $300 million allocated by Ottawa for Gardasil means Canadian taxpayers will be expected to foot a quarter of an international Merck bail-out. And Canadian girls would be the victims.

Thank you for your correspondence of October 4, 2011, addressed to the Honourable Leona Aglukkaq, Minister of Health, concerning the safety of the human papillomavirus (HPV) vaccine GardasilTM. The office of the Prime Minister has also forwarded a copy of your correspondence to the Minister. The Minister has asked me to respond on her behalf.

I would like to take this opportunity to provide you with information on how vaccines, such as GardasilTM, are approved for use in Canada and how the Public Health Agency of Canada (PHAC) monitors for adverse events following immunization.

HPV is one of the most common sexually transmitted infections in Canada. Cervical cancer is caused by HPV; approximately 70 percent of cervical cancers in Canada are caused by HPV strains that the HPV vaccine can protect against. It is estimated that about 1,400 Canadian women will be diagnosed with cervical cancer and nearly 400 deaths will be reported each year. Given these realities, and to protect the health and safety of Canadian girls and women, the federal government approved the use of the HPV vaccine in Canada.

The federal government’s approval of GardasilTM was based on strong scientific evidence. The HPV vaccines are safe and effective in preventing infection with strains of HPV that are responsible for most cervical cancer. Clinical trials for GardasilTM were conducted on more than 30,000 women to substantiate its safety and efficacy. Canada’s National Advisory Committee on Immunization (NACI), an advisory group of infectious disease, immunization, and other medical experts from across Canada, provides PHAC with ongoing and timely medical, scientific and public health advice on vaccines authorized for sale in Canada. In February 2007, based on thorough scientific review and data, NACI recommended GardasilTM vaccine for girls and women. The NACI 2007 Statement on Human Papillomavirus Vaccine can be viewed on the PHAC website at http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/07vol33/acs-02/index-eng.php, and an update to this statement is currently underway and expected to be published, shortly, athttp://www.naci.gc.ca.

Like all medicines, vaccines must undergo several stages of regulatory review to ensure safety, quality and efficacy before they are authorized for sale by Health Canada. Even after a vaccine has been authorized for marketing in Canada, every batch is laboratory
tested for safety and quality. Once a vaccine is in use, Health Canada and PHAC conduct ongoing quality and safety monitoring

Canada has several systems in place to monitor the safety and efficacy of vaccines following immunization. The Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) is a reporting system in which health care providers report to local, provincial and/or territorial public health authorities events they feel are temporally associated with an immunization. In several provinces/territories, Adverse Events Following Immunization (AEFI) reporting by health care professionals is required by jurisdictional Public Health Acts. AEFI reports are forwarded to PHAC by the provinces and territories. In addition, PHAC supports a sentinel network of tertiary care paediatric hospitals known as the Immunization Monitoring Program ACTive. The network actively searches for and reports adverse events following immunization to CAEFISS to improve the timeliness of detection of serious adverse events. Should any of these adverse event reporting systems detect possible safety concerns, action is taken as appropriate.

Since the HPV vaccines were first approved, more than one million doses have been distributed in Canada with no significant safety concerns. The majority of adverse event reports following HPV vaccination, to date, have been of minor adverse events (i.e., rash or fever) which are consistent with the results reported by clinical trials conducted prior to the approval of the vaccines, and can be expected with the administration of any vaccine. None of the adverse events reviewed have suggested any concerning trends or patterns linked to the HPV vaccine in Canada. More information on adverse events related to the GardasilTM vaccine can be found at http://www.phac-aspc.gc.ca/std-mts/hpv-vph/fact-faits-vacc-eng.php#a2.

PHAC and Health Canada work together to monitor, not only the adverse event reports originating in Canada, but also all international evidence relating to the safety of HPV vaccines similar to those marketed in Canada. In the United States, the Centres for Disease Control and Prevention have been carefully monitoring the safety of HPV vaccines and are aware of the concerns expressed on the Internet and have published their review of the vaccine’s safety on its website at the following address: http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html

The World Health Organization’s (WHO) Global Advisory Committee on Vaccine Safety has reviewed the evidence related to HPV vaccines and has expressed no concerns regarding their safety. The WHO reports can be viewed at the following website: http://www.who.int/vaccine_safety/topics/hpv/en/index.html

In the last 50 years, immunization has saved more lives in Canada than any other health intervention. HPV vaccines are an advancement for women’s health, and the federal government’s investment in these vaccines will help to ensure Canadians have access to an important, life-saving vaccine.

It is worthwhile noting that today’s media capabilities and the Internet make information easily available, and it is important to seek out reputable sources when looking for accurate public health information. To help in this regard, the WHO lists websites meeting criteria for good information practices related to credibility and content on vaccine safety at the following website:http://www.who.int/immunization_safety/safety_quality/approved_vaccine_safety_websites/en/

First, although the study showed that the HPV vaccine was modestly effective in reducing AIN3 pre-cancerous lesions in gay men (19 cases in the vaccine group versus 10 cases in the placebo group), it did not show protection against anal cancers per se. As shown in the actual NEJM paper, not a single case of anal cancer even occurred in the study population 2.

Second, AIN3 lesions have a relatively low rate of malignant transformation in the immunocompetent patient, meaning that people with AIN3 mostly die with it, not from it 3. In an earlier issue of Lancet Oncology, a lead researcher in the development of both licensed HPV vaccines noted that, “AIN3 is often benign in hosts other than men who have sex with men or immunosuppressed populations” 3.

Third, only men who had homosexual contacts were used as the HPV vaccine study population, hardly representative of the overall male population for which the HPV vaccine is now being recommended.

As the author of the Lancet paper noted, “The benefit of prophylactic HPV vaccines against anal cancer in the heterosexual male population is unknown: efficacy trials are lacking and anal cancer incidence is rare. Let’s use our resources wisely” 3.

All the HPV vaccine study has shown is that it may prevent some precursor lesions to anal cancer that in most cases will not go on to induce the disease. One is left to question whether the vaccine is urgently needed for disease prevention or serves more to promote the corporate bottom line.

Thank you very much for your email message yesterday morning regarding the plight of Dr. S.H. Lee and the Gardasil vaccine.

I assure you that your correspondence will be brought to Mr. Goodale’s attention at the earliest opportunity. In the meantime, I have contacted the office of our Liberal Health Critic, Dr. Hedy Fry, and asked that she look into this matter as soon as possible.

Thank you for your email to Pat Atkinson. Pat is presently out of country and is stepping down as an MLA when the Premier calls the election next Monday, October 10. As a result, I have forwarded your email to the Health Minister’s office for his information.

Thank you for your encouragements and supports.
I have gone through disappointments and rough times in the early parts of my
life.
The current situation does not bother me that much. Compared with the party
functionaries in China, these people are idiots. Especially now, I know that
I am not alone. I was really alone >50 years ago, in China.
Attached here is something I wrote years ago for my family members, the
younger ones and for some of my close friends.

S. H. (Dr. Lee)
——————————————————————————————————————————————————————————————————————————–Thank you for your message. I have shared it and the attachments with the Provincial Leader of Early Detection in the Saskatchewan Cancer Agency.

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Oct 4, 2011
(In response to my question about any other labs conducting similar work that we could use here in Canada)

Ms Martin,
My PCR method is being used in the Chinese Academy of Sciences Institute of
Biochemistry and Cell Biology in Shanghai.
If Dr. Chris Shaw’s lab in UBC is willing to test the vaccine being
distributed in Canada, I can arrange it after I get back to work to prepare
the reagents (I make my own DNA polymerase). I am almost certain the vaccine
distributed in Canada is also contaminated. The FDA has already admitted
that it is expected and it said they knew it from the very beginning. But
they declare it is no harm.

Best,
S. H.

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Oct 4, 2011
Please replace the version of this one-paged statement with the attached
version. The sentence “Adverse reactions after Gardasil immunization exceed
the death rate in Pap smear screened women in the US” bothers me. So I
replace it with the following.

Thank you for writing to the Prime Minister. In your e-mail, you raised an issue that falls within the portfolio of the Honourable Leona Aglukkaq, Minister of Health.

Please be assured that your comments have been carefully noted. I have taken the liberty of forwarding your e-mail to Minister Aglukkaq. I am certain that the Minister will wish to give your views every consideration.

For more information on the Government’s initiatives, you may wish to visit the Prime Minister’s Web site, at www.pm.gc.ca.

I must admit I have no idea what the manufacturing standards are for DNA presence in a protein/VLP-based vaccine. I am not sure I want to know- sort of like hearing about how many rat hairs or insect parts are permissible per gram of cereal. Since Saccharomyces is the organism which produces these Virus-like particles, I wonder if there is much yeast protein and/or DNA allowed in a normal lot of vaccine. The presence of rDNA in 100% of lots tested by “a private lab” at least suggests consistency. Since we all carry DNA from multiple viruses to which we and our ancestors were exposed, and some of that DNA is linked to increased cancer risk, I can understand the concern.

As Dr Findlater has noted, DNA testing is indeed “fiddly”, with false positive results often requiring multiple steps to validate a screening test. Some private labs don’t seem to believe in admitting a “lower limit” of detection reliability for nucleic acid and antibody tests alike. I have not heard of any efforts here to test Canadian vaccine lots. It may be that there are multiple manufacturing sites, or just a few, serving many countries each. The local pharma reps are usually very good at getting us in touch with their Scientific folks so I’ll see what they can do.

Regards,

Kurt Williams – Immunologist Saskatoon Health Region
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Oct 2, 2011
Dr. Williams,
Yes!
We corresponded on the matter of Tamiflu resistance a few years ago.
On your comments: I agree on the “fiddliness” factor of DNA testing… Dr. Lee had done extensive work in this area to develop more sensitive testing where prior testing methods had failed (false positives or negatives). Hopefully companies that have been producing vaccines for over 50 years should have the protocols that guard against contamination and detect it to ensure it hasn’t happened. The information I found (see the attached abstract) which states that “VLP’s contain no DNA and are therefore the vaccine is not infectious”. http://www.sciencedirect.com/science/article/pii/S0264410X07000357

Dr. Lee’s research was especially interesting due to the fact that he stated that there was an increased risk of women developing cancer after receiving the vaccine that is supposed to protect them from cancer…hmmm…. perhaps this was his first inkling that contamination of the vaccine was possible?”The introduction of the type-specific Gardasil™ HPV vaccines into the sexually active female population also requires genotype monitoring of the HPV infections before and after immunization to develop prevention strategy for the individual patients. Based on a “Background Document” submitted to the FDA [26], injection of HPV vaccines into women who have concurrent vaccine-relevant HPV type infections may increase the risk, by 44.6%, of developing high-grade precancerous lesions in the cervix. Therefore, it would be prudent to perform a genotype-specific HPV assay if prior HPV infection is suspected.”http://www.infectagentscancer.com/content/2/1/11His work in developing a more sensitive and specific assay method is not only groundbreaking, but essential to ensuring safe vaccine production. It is distressing that his research has been prevented from continuing…I appreciate your interest in this matter, and most especially, your offer to investigate what is being done here in Canada.Thanks again for your attention to my concerns,
Sincerely,
Heather Martin
——————————————————————————————————————————————————————————————————————————–From: Findlater, Dr. Ross SktnHR

I guess you must have blind copied me on this email, which was directed to Dr Williams? I am the Saskatoon health region public health doctor working in the immunization area.

It will take me a little time to look into this. I do know that testing for DNA is a very “fiddly” operation in a lab. Other questions which have been raised about Gardasil so far have not shown that there are any significant safety risks identified once the dust settles around a new question.

Vaccines in general in Saskatchewan, including HPV, are given based on consent of the individual involved, or for children, their parents/guardian. So far Gardasil still looks like a very safe and very effective vaccine 3 years after we started the program in Saskatchewan. We have tried to make sure that girls who didn’t get Gardasil when it was first offerred in grade 6 are given a chance to reconsider that decision before they are finished school.

Anyway, I will get back to you once I have been able to gather more information about the issue.